Amgen
brought this action to challenge the decision of the Food and
Drug Administration (“FDA”) denying Amgen
pediatric exclusivity for its drug, Sensipar (cinacalcet
hydrochloride). In an earlier opinion and order, the Court
granted the FDA summary judgment on all but one of
Amgen's claims: its claim that the agency's denial of
pediatric exclusivity for Sensipar was inconsistent with its
decision to grant pediatric exclusivity for Johnson &
Johnson's drug Ortho Tri-Cyclen. Amgen Inc. v.
Hargan, __ F.Supp.3d __, 2018 WL 581006 (D.D.C. Jan. 26,
2018). As to that claim, the Court concluded that the FDA had
failed to offer a “reasoned explanation” for why
it reached a “disparate outcome[]” with respect
to Ortho Tri-Cyclen. Id. at *15-18. On remand, the
FDA reaffirmed its Sensipar decision and explained why, in
its view, this result was consistent with its decision on
Ortho Tri-Cyclen. See AF.2d 1-5 [hereinafter Remand
Decision]. After a last-minute discovery of an additional
document relating to the FDA's Ortho Tri-Cyclen decision,
Dkt. 78, the Court remanded the case to the FDA “to
address [Amgen]'s claim of inconsistent treatment in
light of [the] newly discovered information, ” Minute
Order (Feb. 7, 2018). The FDA issued an addendum to its
Remand Decision, again concluding that its Sensipar and Ortho
Tri-Cyclen decisions were not inconsistent. See
AF.3d 1-4 [hereinafter Remand Addendum]. Amgen has now
renewed its motion for summary judgment on the grounds that
the FDA's latest explanation is inadequate and that its
denial of pediatric exclusivity for Sensipar thus remains
arbitrary and capricious. Dkt. 83. The FDA, in turn, has
renewed its cross-motion for summary judgment. Dkt. 84. For
the reasons that follow, the Court will DENY
Amgen's motion and will GRANT the
FDA's cross-motion.[1]

I.
BACKGROUND

Because
the Court has already recounted the factual and legal
background at length, see Amgen, 2018 WL 581006, at
*1-6, only a brief summary of the background relevant to the
pending motions is necessary. Subject to other requirements
not relevant here, the sponsor of a new drug application will
qualify for six months of pediatric exclusivity if (1) the
FDA determines that “information relating to the use of
[the] new drug in the pediatric population may produce health
benefits in that population, ” 21 U.S.C. §
355a(b)(1); (2) it “issue[s] to the sponsor [of the
drug] a written request for the conduct of pediatric studies
for such drug, ” 21 U.S.C. § 355a(d)(1)(A); and
(3) the sponsor's reports on its pediatric studies are
“submitted [to] and accepted” by the FDA, 21
U.S.C. § 355a(b)(1). The pediatric exclusivity statute
further provides, in relevant part, that the FDA's
“only responsibility in accepting or rejecting the
reports shall be to determine . . . whether the studies
fairly respond to the written request.” 21
U.S.C. § 355a(d)(4) (emphasis added). Under the
FDA's interpretation of this provision, the “fairly
respond” requirement is satisfied if a sponsor
“meets the terms” of the written request or if
the sponsor's studies yield information that is
“clinically meaningful across all age groups and uses
cited” in the request, thus satisfying the objectives
of the request. AR 1637.

The FDA
denied Amgen's request for pediatric exclusivity for
Sensipar because Amgen's studies did not, in the
agency's view, “fairly respond” to the
written request, AR 1389, and it reaffirmed that decision in
subsequent administrative proceedings, AR 1484; AR 1632.
According to the FDA, Amgen's studies did not fully
comply with the requirements of the written request: for one
of the studies, the written request required a minimum of
fifteen patients ages 28 days to < 6 years, but only four
patients completed the study, AR 1645, and, in the FDA's
view, Amgen's data did not yield “clinically
meaningful” information on cinacalcet's safety in
that age group-a key objective of the written request, AR
1647-48. Amgen brought this action under the Administrative
Procedure Act, 5 U.S.C. § 701 et seq., to
challenge the FDA's denial of pediatric exclusivity for
Sensipar. Dkt. 1 at 2 (Compl. ¶ 1). Both parties moved
for summary judgment.

On
January 26, 2018, the Court issued a memorandum opinion and
order resolving most of Amgen's claims in the FDA's
favor. Amgen, 2018 WL 581006, at *21. But the Court
granted summary judgment in favor of Amgen on the limited
ground that the FDA had failed to offer a “reasoned
explanation” for why it reached a “disparate
outcome[]” in the case of Johnson & Johnson's
Ortho Tri-Cyclen. Id. The written request for Ortho
Tri-Cyclen required Johnson & Johnson to complete a study
involving at least 120 adolescent women with anorexia nervosa
as defined by the Diagnostic and Statistical Manual of Mental
Disorders, fourth edition (“DSM-IV”). AR 1872.
Johnson & Johnson received pediatric exclusivity in
December 2003. AF.2d 4. More than a year later, however, a
clinical reviewer for the FDA, Dr. Brenda Gierhart, concluded
that “the majority of the 123 subjects treated . . .
did not meet . . . the DSM-IV diagnostic criteria
for anorexia nervosa.” AR 1916. Relying on this
observation, Amgen asserted that it was arbitrary and
capricious for the FDA to deny pediatric exclusivity for
Sensipar after granting that benefit to another sponsor that
neither met the terms of the written request nor achieved its
objectives. Dkt. 60-1 at 45.

The
Court concluded that, because the FDA's administrative
determination did not “explain [its] rationale and [did
not] identify the relevant evidence, ” the Sensipar
decision was “at least in this one respect . . .
arbitrary and capricious.” Amgen, 2018 WL
581006, at *17. But the Court also noted that “[t]here
may be an answer to Amgen's contention, ”
including, for instance, that “Johnson &
Johnson's study did, in fact, comply with the
requirement[s]” of the written request, or that the FDA
granted Johnson & Johnson pediatric exclusivity
“based on the mistaken belief that [the study] was
conducted in full compliance with the terms of the written
request” and “the failure to enroll patients
meeting the DSM-IV criteria was discovered only after the
fact.” Id. The Court, accordingly, remanded
the case to the FDA “for the limited purpose of
addressing whether the agency's prior decision granting
pediatric exclusivity for Ortho Tri-Cyclen is consistent with
its decision denying pediatric exclusivity for Sensipar and,
if not, whether there is a reasoned explanation for the
disparate outcomes.” Id. at *21.

The FDA
issued its Remand Decision and supplemented the
administrative record on February 5, 2018. See
Remand Decision. The FDA explained in its Remand Decision
that it granted pediatric exclusivity to Ortho Tri-Cyclen
based on the agency's understanding in December 2003,
when it was statutorily required to make the exclusivity
determination, that Johnson & Johnson's studies met
the terms of the written request. Id. at 1, 3-4. The
FDA cited several internal documents that, it asserted, show
that it believed Johnson & Johnson had “fulfill[ed]
the terms” of the written request when
“eligibility for [pediatric exclusivity] was
decided.” Id. at 3. The FDA further explained
that “the realization that a majority of enrolled study
subjects had not, in fact, met DSM-IV criteria for [anorexia
nervosa] came after [Johnson & Johnson's] final study
reports had been submitted . . . and evaluated” and
“postdates the [exclusivity] decision.”
Id. at 4. The agency therefore concluded that it
applied the same standard to both Ortho Tri-Cyclen and
Sensipar and that Amgen's failure to meet the terms of
its written request distinguishes the agency's
exclusivity denial for Sensipar from the agency's grant
of exclusivity for Ortho Tri-Cyclen. Id. at 4.

The day
after it issued its Remand Decision, the FDA notified the
Court that it had discovered an additional document showing
that, before the FDA granted pediatric exclusivity
for Ortho Tri-Cyclen, it asked Johnson & Johnson whether
its study “subjects met the enrollment criteria.”
Dkt. 78 at 3. The Court held a status conference the
following day. In light of the parties' representations
at the status conference, the Court again remanded the case
to the FDA to address the relevance of the “newly
discovered information” to its Remand Decision and set
an expedited briefing schedule. Minute Order (Feb. 7, 2018).

On
February 8, 2018, the FDA issued an addendum to its Remand
Decision and further supplemented the administrative record
with newly discovered documents relating to its Ortho
Tri-Cyclen decision. See Remand Addendum. These
documents fill in several holes in the timeline discussed
above. First, and most significantly, the medical officer who
reviewed the interim Ortho Tri-Cyclen data, Dr. Eric Colman,
contacted Johnson & Johnson before he
recommended granting exclusivity to ask “whether all of
the subjects had Body Mass. Index (BMI) values below the 10th
percentile for age.” Id. at 1-2; see
AF.3d 7. This benchmark, the FDA explains, provides one way
to “fulfill[] one of the DSM-IV criteria.” Remand
Addendum at 1 n.5. Second, Johnson & Johnson responded to
the FDA's inquiry on December 5 and December 8, 2003-once
again, before the FDA granted exclusivity on
December 18. Id. at 2; see AF.3d 10-12,
14-18. Johnson & Johnson indicated that 74 out of 123
patients had BMIs above the tenth percentile, and it
“provided a rationale that purported to explain why, in
[its] opinion, the terms of the [written request] had been
met.” Remand Addendum at 2. Third, Dr. Colman
“contributed to the annotated Written Request for the
Pediatric Exclusivity Board, which concluded . . . that
‘[a]ll patients had a diagnosis of [anorexia nervosa]
by DSM-IV criteria.'” Id. (quoting AF.2d
18); see also AF.3d 13. Finally, as noted, Dr.
Colman recommended granting exclusivity on the grounds that
“the requested study was conducted in agreement with
the [w]ritten [r]equest.” AR 1885; see Remand
Addendum at 2.

In
light of these new records, the FDA's Remand Addendum
“correct[s] a factual inaccuracy in the [original]
Remand Decision, ” acknowledging that the “FDA
questioned whether subjects met the enrollment criteria
before the date of the [e]xclusivity [d]ecision,
contrary to what the Remand Decision stated.” Remand
Addendum at 1-2. But the new records, in the FDA's view,
do not alter its conclusion that it applied the same standard
to Sensipar and Ortho Tri-Cyclen. According to the FDA, the
Sensipar studies fell short of full compliance with the
written request, whereas the “FDA determined that the
DSM[-]IV criteria had been met” when it granted
exclusivity for Ortho Tri-Cyclen. Id. at 4.
Reflecting some uncertainty about what happened, the
FDA's Remand Addendum also advances two alternative
arguments: (1) that the requirement that study subjects meet
the DSM-IV criteria was not, in fact, a requirement at all
but a mere recommendation or suggestion, id. at 3;
and (2) that “it cannot be entirely ruled out that
[the] FDA relied on some other rationale to determine Ortho
Tri-Cyclen's eligibility for [exclusivity]” and
“[e]ven if [the] FDA were mistaken about whether the
enrollment criteria were met . . ., that mistake would not
justify making a similar mistake when evaluating other
sponsors' studies, ” id. at 4.

Amgen
has now renewed its motion for summary judgment with respect
to its claim of inconsistent treatment. See Dkt. 83.
It asserts that “there is nothing in the record that
explains the [Pediatric Exclusivity] Board's . . .
analysis, ” id. at 3, and that the FDA's
“current musings are completely implausible in light of
the record, ” which shows that a majority of the Ortho
Tri-Cyclen subjects “did not meet the specified
enrollment criteria, ” id. at 5-6. Amgen
further contends that, to the extent the FDA applied
different “fairly respond” standards to Sensipar
and Ortho Tri-Cyclen, its decision on Ortho Tri-Cyclen
“reinvigorates” Amgen's fair notice and
retroactive rulemaking arguments. Id. at 8; see
Id. at 6-8. The FDA has also renewed its motion for
summary judgment. Dkt. 84. The agency contends that it
applied the same standard to both applications and that the
FDA decided that the Ortho Tri-Cyclen studies “met the
enrollment criteria in the [written request] at the time of
the [exclusivity] decision.” Id. at 3.

II.
ANALYSIS

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Amgen,
as the party challenging the FDA&#39;s exclusivity decision,
&ldquo;has the burden of showing that the agency action was
&lsquo;arbitrary, capricious, an abuse of discretion, or
otherwise not in accordance with law.&#39;&rdquo;
Advocates for Highway & Auto Safety v. Fed. Motor
Carrier Safety Admin., 429 F.3d 1136, 1144 (D.C. Cir.
2005) (quoting 5 U.S.C. &sect; 706(2)(A)). &ldquo;The scope
of review under the &lsquo;arbitrary and capricious&#39;
standard is narrow and a court is not to substitute its
judgment for that of the agency.&rdquo; Motor Vehicle
Mfrs. Ass&#39;n of U.S., Inc. v. State Farm Mut. Auto. Ins.
Co., 463 U.S. 29, 43 (1983). This rule &ldquo;applies
with particular force in a case, like this one, involving
scientific analysis and &lsquo;technical
expertise.&#39;&rdquo; Nat. Res. Def. Council, Inc. v.
Rauch, 244 F.Supp.3d 66, 86 (D.D.C. 2017) (quoting
Marsh v. Or. Nat. Res. Council, 490 U.S. 360, 377
(1989)). &ldquo;When specialists express conflicting views,
&rdquo; for example, &ldquo;an agency must have discretion to
rely on the reasonable opinions of its own qualified experts
even if, as an original matter, a court might find contrary
views more persuasive.&rdquo; Marsh, 490 U.S. at
378. That said, the Court must satisfy itself that the agency
...

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